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Follow-On Biologics: The Law and Intellectual Property Issues

Summary

The term “biologics” refers to a category of medical preparations derived from a living organism. These medicines have added notable therapeutic options for many diseases and impacted fields such as oncology and rheumatology. The biologics industry invests extensively in R&D and contributes to a rapidly expanding market for these treatments. Biologics are often costly, however, in part due to the sophistication of the technologies and the manufacturing techniques needed to make them.

Some commentators have also observed that, in contrast to the generic drugs available in
traditional pharmaceutical markets, few “follow-on” biologics compete with the original, brandname product. The lack of competition in the biologics markets is perceived to be a consequence of the complexity of biologics in comparison with small-molecule, chemical-based pharmaceuticals. As a result, previously existing accelerated marketing provisions for traditional generic drugs provided under the Federal Food, Drug, and Cosmetic Act do not comfortably apply to biologics.

Congress turned to these concerns when it enacted the Biologics Price Competition and
Innovation Act (BPCIA) of 2009. The BPCIA was incorporated into Title VII of the Patient
Protection and Affordable Care Act. The BPCIA included three significant components. First, the BPCIA established a licensure pathway for competing versions of previously marketed biologics. In particular, the legislation established a regulatory regime for two sorts of follow-on biologics, termed “biosimilar” and “interable” biologics. The Food and Drug Administration (FDA) was afforded a prominent role in determining the particular standards for biosimilarity and interability for individual products.

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